Revised Common Rule

Effective January 19, 2018, several revisions to the human subjects research regulations known as the Common Rule will go into effect. NDSU IRB Standard Operating Procedures have been modified to comply with the revised regulations. NDSU will utilize the following six (6) exemption categories. Protocol applications for review can be found below, or on the 'Forms' page.

EXEMPTION CATEGORY:

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

NOTE: Research involving normal educational practices in this category may include various methods and types of data (including identifiable data), such as:

Examples of educational research which may not qualify under this category include:

· Research conducted by department or program chairs who also hold responsibility for evaluation of faculty,

· Research involving the assignment of students to either a proven educational technique or a novel educational technique (i.e. experimental or quasi-experimental design).

When academic records will be used for research, the investigator is responsible for compliance with the Family Educational Rights and Privacy Act (FERPA). Refer to SOP 11.1 Use of Confidential Records and the Office of Registration and Records for more information.

Category 2: Research involving educational tests, survey or interview procedures, or observation of public behavior

Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or

(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §___.111(a)(7)

NOTE: This category has limited applicability where children will be involved: research involving educational tests, or public observation where the investigator does not take part in the activities being observed. Surveys or interviews of children are not included in this category.

Category 3: Benign Behavioral Interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or

(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §___.111(a)(7).

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

This category may not include children.

Category 4: Secondary research for which consent is not required

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;

(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use if regulated under 45 CFR parts 160- and 164, subparts A and E [HIPAA], for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S. C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S. C. 3501 et seq.

* By “secondary research,” this exemption is referring to re-using identifiable information and identifiable biospecimens that are collected for some other ‘primary” or “initial” activity. The information or biospecimens that are covered by this exemption would generally be found by the investigator in some type of records (in the case of information) or some type of tissue repository (such as a hospital’s department for storing clinical pathology specimens).

* In relation to Exemption 4(i), examples of identifiable information or identifiable biospecimens which are publicly available, include:

o Use of archives in a public library,

o Government or other institutional records where public access is provided on request,

o From a commercial entity if the information is provided to members of the public on request of if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor to an archive,

o A commercial entity made identifiable biospecimens publicly available to anyone on request or for a fee.

* NDSU is NOT a HIPAA Covered Entity (CE); therefore, exemption 4(iii) may not be used unless the research will take place at a covered entity and that entity determines through their IRB procedures that the exemption applies or NDSU Formally enters into a Business Associate Agreement with the CE.

* It is important to recognize that this exemption does not cover any primary collections of either information or biospecimens. For example, if an investigator wants to collect information directly from research subjects by asking them to complete a questionnaire, that would not be covered by this exemption. If an investigator wants to collect biospecimens by having subjects swab their cheek, that would similarly not be covered by this exemption.

Category 5: Public Benefit or Service Programs

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

NOTE: Guidance from OHRP indicates that institutions should consult the HHS funding agency before invoking this exemption. In addition, it clarifies that:

1) The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).

2) The research or demonstration project must be conducted pursuant to specific federal statutory authority.

3) There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).

4) The project must not involve significant physical invasions or intrusions upon the privacy of participants.

* food ingredient or additive at or below the level and for a use found to be safe by the Food and Drug Administration, or

* agricultural chemical or environmental contaminant at or below the level found to be safe, approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.